MAUDE Adverse Event Report: AD-TECH MEDICAL INSTRUMENT CORP. DISPOSABLE DRILL KIT; CRANIAL DRILL BIT

Model Number	DDK2-2.4-30X
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The tip was received using fluoroscopy and the surgeon ((b)(6)) requested that the drill kit to be submitted for analysis.The pathologist stated that the product is available for return for analysis.
Event or Problem Description
On 12/20/2023 it was communicated by email that during a depth electrode implantation on (b)(6) 2023, a drill kit tip sheared off into the temporalis muscle of the patient.The patient needed an intraopertaive x-ray to visualize and localize the drill bit to facilitate removal.The tip was received using fluoroscopy and no patient harm was reported.
Additional Manufacturer Narrative
The tip was received using fluoroscopy and the surgeon (dr.Sagher) requested that the drill kit to be submitted for analysis.The pathologist stated that the product is available for return for analysis.Updated 02/01/2024 the product was returned to ad-tech for evaluation.During the evaluation, a visual examination was conducted and found the returned drill bit to be in two pieces thus confirming the alleged deficiency.Therefore, the damage to healthy tissue is being evaluated against the use fmea since the deficiency is a result of the use of the drill kit and not a result of the process or testing of the drill kit.The doctor has confirmed that the trajectory was a steep angle by design, which could be the potential root cause of the break of the drill bit.The risk file matches the risk file referenced in the preliminary risk assessment and the resulting risk level will remain "alap".
Event or Problem Description
On 12/20/2023 it was communicated by email that during a depth electrode implantation on (b)(6) 2023, a drill kit tip sheared off into the temporalis muscle of the patient.The patient needed an intraoperative x-ray to visualize and localize the drill bit to facilitate removal.The tip was received using fluoroscopy and no patient harm was reported.
Event or Problem Description
On 12/20/2023 it was communicated by email that during a depth electrode implantation on (b)(6) 2023, a drill kit tip sheared off into the temporalis muscle of the patient.The patient needed an intraopertaive x-ray to visualize and localize the drill bit to facilitate removal.The tip was received using fluoroscopy and no patient harm was reported.
Additional Manufacturer Narrative
The tip was received using fluoroscopy and the surgeon (dr.Sagher) requested that the drill kit to be submitted for analysis.The pathologist stated that the product is available for return for analysis.----updated 02/01/2024--- the product was returned to ad-tech for evaluation.During the evaluation, a visual examination was conducted and found the returned drill bit to be in two pieces thus confirming the alleged deficiency.Therefore, the damage to healthy tissue is being evaluated against the use fmea since the deficiency is a result of the use of the drill kit and not a result of the process or testing of the drill kit.The doctor has confirmed that the trajectory was a steep angle by design, which could be the potential root cause of the break of the drill bit.The risk file matches the risk file referenced in the preliminary risk assessment and the resulting risk level will remain "alap"."udi related data quality updates only" ---- updated 9/23/24------- clarification and correction of the following missing items from previous supplemental report: combination product- no.Brand name- disposable drill kit.Model number ddk2-2.4-30x.Primary di number-(b)(4).Labeled for single use - yes.

• Brand Name: DISPOSABLE DRILL KIT
• Common Device Name: CRANIAL DRILL BIT
• Manufacturer (Section D): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek WI 53154
• Manufacturer (Section G): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek WI 53154
• Manufacturer Contact: monique-elise alamina ; 400 west oakview parkway; oak creek, WI 53154 ; 2626341555
• MDR Report Key: 18428418
• Report Number: 2183456-2024-00001
• Device Sequence Number: 7771618
• Product Code: HBE
• UDI-Device Identifier: 00841823101167
• UDI-Public: 00841823101167
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K170442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DDK2-2.4-30X
• Device Catalogue Number: DDK2-2.4-30X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2023
• Supplement Date Received by Manufacturer: 12/20/2023; 12/20/2023
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 02/01/2024; 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown